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Home › Online Training ›Medical device Training ›  R & D

Medical Device R&D Regulatory Compliance Training - Live Webinars, Recordings & CDs

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Introduction to Root Cause Investigation for CAPA
21
/ Feb
Thursday-2019

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
* Per Attendee
$229
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FDA Regulations for Environmental Monitoring (EM) Program
4
/ Mar
Monday-2019

FDA Regulations for Environmental Monitoring (EM) Program

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 90 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
* Per Attendee
$199
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Risk Analysis in Medical Device Design
14
/ Mar
Thursday-2019

Risk Analysis in Medical Device Design

  • Speaker: Charles H Paul
  • Product ID: 704803
  • Duration: 60 Min
This medical device risk assessment webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective device Risk or Hazard Analysis.
* Per Attendee
$229
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Technical Writing for Medical Products: SOPs, Investigations and Change Records
14
/ Mar
Thursday-2019

Technical Writing for Medical Products: SOPs, Investigations and Change Records

  • Speaker: Regina Fullin
  • Product ID: 704304
  • Duration: 60 Min
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
* Per Attendee
$229
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Process Challenge Device Development for EO Sterilization
26
/ Mar
Tuesday-2019

Process Challenge Device Development for EO Sterilization

  • Speaker: Gerry O Dell
  • Product ID: 703443
  • Duration: 90 Min
This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.
* Per Attendee
$249
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Recorded/CD
Understanding FDA Design Verification and Validation Requirements for Medical Devices

Understanding FDA Design Verification and Validation Requirements for Medical Devices

  • Speaker: Meena Chettiar
  • Product ID: 705331
  • Duration: 75 Min
This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.
CD/Recorded
$299
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Recorded/CD
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

  • Speaker: Robert J Russell
  • Product ID: 705370
  • Duration: 90 Min
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
CD/Recorded
$249
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Recorded/CD
Cell Based Assays: Development and Validation

Cell Based Assays: Development and Validation

  • Speaker: Michael Simonian
  • Product ID: 704528
  • Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
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Recorded/CD
Human Factors Engineering in New Product Development

Human Factors Engineering in New Product Development

  • Speaker: Tom Kramer
  • Product ID: 705153
  • Duration: 120 Min
This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.
CD/Recorded
$249
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Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$249
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Recorded/CD
The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.
CD/Recorded
$249
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Recorded/CD
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
CD/Recorded
$249
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Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
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Recorded/CD
How to Prepare for the New EU Medical Device Regulations

How to Prepare for the New EU Medical Device Regulations

  • Speaker: Richard Young
  • Product ID: 705513
  • Duration: 90 Min
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
CD/Recorded
$279
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Recorded/CD
How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®

How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®

  • Speaker: Jerry Phillips
  • Product ID: 705281
  • Duration: 90 Min
This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.
CD/Recorded
$249
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Recorded/CD
Post-market Surveillance - Clinical Evaluation and Risk Management

Post-market Surveillance - Clinical Evaluation and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 705402
  • Duration: 90 Min
This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.
CD/Recorded
$249
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Recorded/CD
How to Interpret Probability Plots

How to Interpret Probability Plots

  • Speaker: Jerry Phillips
  • Product ID: 705161
  • Duration: 90 Min
This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.
CD/Recorded
$249
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Recorded/CD
Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success

  • Speaker: Meena Chettiar
  • Product ID: 705400
  • Duration: 60 Min
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
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Recorded/CD
Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

  • Speaker: Edwin Waldbusser
  • Product ID: 705432
  • Duration: 60 Min
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
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Recorded/CD
E-Submissions and Data Standards for FDA (eCTD, CDISC, HL7)

E-Submissions and Data Standards for FDA (eCTD, CDISC, HL7)

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
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